|
Device | BVI 1% OVD (formerly BD 1% OVD and Biolon) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Altacor Ltd. Merlin House, Brunel Road Theale RG7 4 |
PMA Number | P960011 |
Supplement Number | S029 |
Date Received | 02/12/2018 |
Decision Date | 03/15/2018 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the labeling trade name from BVI 1% OVD® (1% sodium hyaluronate viscoelastic surgical aid fluid) to BIOLON, distributor, and Instructions for Use for the inclusion of a tamper-evident tip cap closure system. |